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The iVent101 ventilator [with single or dual limb configuration] is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for infants from 5 kg through adult patients who require invasive or non-invasive support via the following ventilatory modalities: - Assist/Control and SIMV with either Volume, Pressure, or Pressure Regulated . Volume Control (PRVC) - CPAP with Pressure Support . - Adaptive Bi-Level for either NIV or invasive ventilation. ● The iVent101 ventilator is suitable for use in institution, home and portable settings.

The iVent101 is a compact, portable, microprocessor-controlled ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation .A turbine-powered air source and a rechargeable internal battery provide freedom from wall air and power outlets . Internal flow and pressure are read through flow/pressure sensors. Clinical data [Tidal Volume, Rate, PIP, FiO2, Peak Flow, Inspiratory Time, I:E Minute Volume] are presented on machine screen. All the operator actions are performed on the LCD touch-screen on the front panel, allows, rapid control and continuous real-time monitoring of patient ventilation. · Alarm settings are fully adjustable. Optional Waveform and Diagnostic Software package displays pressure and flow waveform data, loops, trends, and logged totals in a full array of time slices and presentation modes. The iVent101 can use external AC or DC power supply and contains an integrated battery. The iVention is equipped with two configurations, which differs in the patient circuit type that connects to the machine. One configuration is to be used with a standard one limb patient circuit, and the second configuration is to be used with a standard dual limb patient circuit. The two configurations are incorporating the same infrastructure and can be easily replaced by the user. The iVent101 is capable of providing the following types of ventilatory support: - Assist/Control and SIMV with either Volume, Pressure, or Pressure Regulated . Volume Control (PRVC) - CPAP with Pressure Support - Adaptive Bi-Level for either NIV or invasive ventilation. .

The iVent™ 201 MR Conditional is a portable, computer controlled, electrically powered intensive care ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for use with adult through pediatric patients, who require invasive or non-invasive assistance via the following general modes of ventilatory support, as prescribed by an attending physician: - Assist/Control (Pressure Controlled or Volume Controlled) - SIMV (Pressure Controlled or Volume Controlled) - CPAP/PSV The iVent™ 201 MR Conditional ventilator is suitable for use in the ICU and all other hospital areas, including Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field, in all hospital-type facilities, alternate care sites, transport, emergency and in the home environment. The iVent™ 201 MR Conditional ventilator is MR Conditional. The optional non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate and is suitable for use in all above mentioned areas, excluding MR environments. The iVent™ 201 MR Conditional ventilator is a restricted medical device intended for use by qualified, trained personnel under the direct supervision of a physician.

The iVent™ 201 MR Conditional is a compact, portable, fully featured, microprocessorcontrolled ventilator offering the versatility and capability of larger and costlier ventilators. A turbine-powered air source and a rechargeable internal battery provide freedom from wall air and power outlets. An intuitive turn and click control knob, quick choice push buttons, and a bright, well-organized, easy-to-read screen allow rapid control and continuous real-time monitoring of patient ventilation. Alarm settings are fully adjustable. Optional Waveform and Diagnostic Software package displays pressure and flow waveform data, loops, trends, and logged totals in a full array of time slices and presentation modes. Optional equipment: - Non-invasive pulse oximeter (not to be used in MR environments) . - . Remote Alarm Adapter Testing has been performed according to ASTM F2052-06-e1 in 1.5 and 3.0 Tesla environments.

The iVenf™ 201 is a portable, computer controlled, electrically powered intensive care ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for use with adult through pediatric patients, who require the following general modes of ventilatory support, as prescribed by an attending physician: - Assist/Control (Pressure Controlled or Volume Controlled) . - SIMV (Pressure Controlled or Volume Controlled) . - . CPAP/PSV The iVently 201 ventilator (with or without the non-invasive Pulse Oximeter option) is suitable for use in the ICU and all other hospital areas. in all hospital-type facilities. alternate-care sites, transport, emergency and in the home environment. The non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate and is suitable for use in all above mentioned areas. The iVent™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician

The iVent201 is a compact, portable, fully featured, microprocessor-controlled ventilator offering the versatility and capability of larger and costlier ventilators. A turbine-powered air source and a rechargeable internal battery provide freedom from wall air and power outlets. An intuitive turn-and-click control knob, quick-choice pushbuttons, and a bright, well-organized, easy-to-read screen allow rapid control and continuous real-time monitoring of patient ventilation. Alarm settings are fully adjustable. Optional Waveform and Diagnostic Software package displays pressure and flow waveform data, loops, trends, and logged totals in a full array of time slices and presentation modes. Description of Non- invasive Pulse Oximeter: The Non-invasive Pulse Oximeter connects to sensors and provides oxygen saturation, pulse rate, pulse waveform, and other output information via a serial digital interface. The iVent 201 systems provide isolated DC power. The Non-invasive Pulse Oximeter board is mounted internal to the iVent 201 unit and is part of the electronic configuration of the unit. Connection of the Pulse Oximeter accessories is via a connector on the back panel of the unit. Description of remote Alarm Adaptor: The adapter connects between a Remote Alarm outlet on the iVent 201 Ventilator and the Central Remote Alarm unit of the Hospital. The adapter consists of a relay circuit, which meets activating requirements of the Central Remote Alarm unit.The iVent 201 Ventilator with Remote Alarm Adapter will activate the Central Remote Alarm unit for any major or medium priority alarm event that occurs on the unit.

The iVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lb.), who require the following general modes of ventilatory support, as prescribed by an attending physician: - Assist/Control (Pressure Controlled or Volume Controlled) - SIMV (Pressure Controlled or Volume Controlled) - CPAP/PSV The iVent™ 201 ventilator with Non-invasive Pulse Oximeter is suitable for intra-hospital use, home and alternate-site use, transport and emergency use. The Non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate. The iVent™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician and within the technical specification limits.

The iVent201 is a compact, portable, fully featured, microprocessor-controlled ventilator offering the versatility and capability of larger and costlier ventilators. A turbine-powered air source and a rechargeable internal battery provide freedom from wall air and power outlets. An intuitive turn-and-click control knob, quick-choice pushbuttons, and a bright, well-organized, easy-to-read screen allow rapid control and continuous real-time monitoring of patient ventilation. Alarm settings are fully adjustable. Optional Waveform and Diagnostic Software package displays pressure and flow waveform data, loops, trends, and logged totals in a full array of time slices and presentation modes. Description of Non- invasive Pulse Oximeter: The Non-invasive Pulse Oximeter connects to sensors and provides oxygen saturation, pulse waveform, and other output information via a serial digital interface. The iVent 201 systems provide isolated DC power. The Non-invasive Pulse Oximeter board is mounted internal to the iVent 201 unit and is part of the electronic configuration of the unit. Connection of the Pulse Oximeter accessories is via a connector on the back panel of the unit. Description of remote Alarm Adaptor: The adapter connects between a Remote Alarm outlet on the iVent 201 Ventilator and the Central Remote Alarm unit of the Hospital. The adapter consists of a relay circuit, which meets activating requirements of the Central Remote Alarm unit.The iVent 201 Ventilator with Remote Alarm Adapter will activate the Central Remote Alarm unit for any major or medium priority alarm event that occurs on the unit.

The iVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lb.), who require the following general modes of ventilatory support, as prescribed by an attending physician: - · Assist/Control (Pressure Controlled or Volume Controlled) - · SIMV (Pressure Controlled or Volume Controlled) - · CPAP/PSV The iVent™ 201 ventilator with Non-invasive Pulse Oximeter is suitable for intra-hospital use, home and alternate-site use, transport and emergency use. The Non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate. The iVeur™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician and within the technical specification limits.

The iVent201 is a compact, portable, fully featured, microprocessor-controlled ventilator offering the versatility and capability of larger and costlier ventilators. A turbine-powered air source and a rechargeable internal battery provide freedom from wall air and power outlets. An intuitive turn-and-click control knob, quick-choice pushbuttons, and a bright, well-organized, easy-to-read screen allow rapid control and continuous real-time monitoring of patient ventilation. Alarm settings are fully adjustable. Optional Waveform and Diagnostic Software package displays pressure and flow waveform data, loops, trends, and logged totals in a full array of time slices and presentation modes. Description of Non- invasive Pulse Oximeter: The Non-invasive Pulse Oximeter connects to sensors and provides oxygen saturation, pulse rate, pulse waveform, and other output information via a serial digital interface. The iVent 201 systems provide isolated DC power. The Non-invasive Pulse Oximeter board is mounted internal to the iVent 201 unit and is part of the electronic configuration of the unit. Connection of the Pulse Oximeter accessories is via a connector on the back panel of the unit. Description of remote Alarm Adaptor: The adapter connects between a Remote Alarm outlet on the iVent 201 Ventilator and the Central Remote Alarm unit of the Hospital. The adapter consists of a relay circuit, which meets activating requirements of the Central Remote Alarm unit.The iVent 201 Ventilator with Remote Alarm Adapter will activate the Central Remote Alarm unit for any major or medium priority alarm event that occurs on the unit.

The Went™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric putients weight 10 kg (22 lb.), who require the following general modes of ventilatory support, as prescribed by an attending physician: - Assist/Control (Pressure Controlled or Volume Controlled) . - SIMV (Pressure Controlled or Volume Controlled) . - CPAP/PSV . The iVent™ 201 ventilator with Non-invasive Puise Oximeter is suitable for intra-hospital use, home and alternate-site use, transport and emergency use. The Non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate. The iVent™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician and within the technical specification limits.

The iVent201 is a compact, portable, fully featured, microprocessor-controlled ventilator offering the versatility and capability of larger and coptivessor vontilators. A turbine-powered air source and a rechargeable internal battery provide freedam from wall air and power outlets. An intuitive turn-and-click control knob, quick-choice pushbuttons, and a bright, well-organized, easy-to-read screen allow rapid control and continuous real-time monitoring of patient ventilation. Alam settings are fully adjustable. Optional Waveform and Diagnostic Software package displays pressure and flow waveform data, loops, trends, and logged totals in a full array of time slices and presentation modes. Description of Non- invasive Pulse Oximeter (Cleared under K 021981): The Noninvasive Pulse Oximeter connects to sensors and provides oxygen saturation, pulse rate, pulse waveform, and other output information via a serial digital interfor. The iVent 201 systems provide DC power and isolation to the board from the mains power and ground. The Non-invasive Pulse Oximeter board is mounted internal to the iVent 201 unit and is part of the electronic configuration of the unit. Connection of the Pulse Oximeter accessories is via a connector on the back panel of the unit. Description of remote Alarm Adaptor (cleared under K 011957): The adapter connects between a Remote Alarm outlet on the iVent 201 Ventilator and the Central Remote Alarm unit of the Hospital. The adapter consists of a relay circuit, which meets activating requirements of the Central Remote Alarm unit.The iVent 201 Ventilator with Remote Alarm Adapter will activate the Central Remote Alarm unit for any major or medium priority alarm event that occurs on the unit.