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The LTV® 1200 ventilator is intended to provide continuous or intermittent ventilatory support for the care of the 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 adult and pediatric patients weighing at least 5kg (11 lbs.), who require the following types of ventilatory support: Positive Pressure Ventilation, delivered invasively (via endotrach tube or trach tube) or non-invasively (via mask or nasal prongs). Assist/Control, SIMV, CPAP, or NPPV modes of ventilation. The ventilator is suitable for use in institutional, home, or transport settings. The MR Conditional LTV® 1200 System is suitable for use in both 1.5 and 3.0 Tesla (not to exceed 3.0 Tesla static magnetic field) shielded magnetic scanners. CAUTION: Federal law restricts this device to sale by or on the order of a physician.

The LTV 1200 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in institutional, home and transport settings, and is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support: Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask). Assist/Control, SIMV, CPAP, or NPPV modes of ventilation. Breath types including Volume, Pressure Control and Pressure Support. The modification intended to be cleared by this submission is: The "Indications for Use" is being expanded to label the LTV 1200 as MR Conditional. The LTV 1200 Ventilator, previously cleared for homecare, institutional and transport use is now being submitted for clearance with the listed modification.

PALMTop PTV Models 8/10 are designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). They are suitable for service in homecare, hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively. PALMTop Ventilators are restricted medical devices intended for operation by trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations. Federal law (USA) restricts the sale of this device except by or on the order of a physician.

The PALMTop PTV Models 8/10 are designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). They are suitable for service in homecare, hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively. The PTV platform provides for the following features: - . High performance ventilation in a small lightweight package - A range of maneuvers including Inspiratory and Expiratory hold . and synchronized Nebulization (touch screen models only) - . Internal flow generator, allowing the PTV to operate without an external compressed gas source - . Four distinct breath types offering a range of treatment options. CPAP with optional Pressure Support 1, SIMV2, Control, Assist / Control - Configurable Apnea back-up ventilation . - NPPV3 ventilation, providing an alarm package suitable for . mask ventilation of patients whose needs do not extend to life support - Volume Control, Pressure Control and PRVC4 ventilation modes t - Adjustable alarm settings including High Peak Pressure. Low . Peak Pressure, Low Minute Volume, and Apnea - Oxygen blending from a high-pressure oxygen source (optional) . or low-pressure oxygen bleed-in - Lockable front panel controls . - A wide range of monitors including Breath Rate (f), I:E Ratio . (Measured), MAP, Exhaled Minute Volume (VE), PEEP, PIP and Tidal Volume (Vte) - Dynamic waveform and loop displays . - . Graphic trending histogram display - Real-time patient circuit pressure display . - . Variable termination options for Pressure Support breaths, including maximum inspiratory time and percentage of peak flow - . Selectable Percentage of Peak Flow termination for Pressure Control breaths - Leak Compensation to improve patient triggering when a circuit . leak is present - . Operation from a variety of power sources including AC power. removable battery and external DC power sources - . Optional FIO2 sensor package. - . Optional Oximetry module

The LTV 1200 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilation is a restricted medical device intension of individuals who require incomment venture direction of a physician. Specifically, the ventilator is applicable for adult and petiative weighing at least 5 kg (1 1 lbs), who require the following types of ventilatory support: - Positive Pressure Yentilation, delivered invasively (via ET tube) or non-invasively (via mask). Assist/Control, SIMV, CPAP, or NPPV modes of ventilation. The ventilator is suitable for use in institutional, home, or transport settings.

The LTV 1200 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in institutional, home and transport settings, and is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support: - Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via . mask). - Assist/Control, SIMV, CPAP, or NPPV modes of ventilation. . - Breath types including Volume, Pressure Control and Pressure Support. . The modifications intended to be cleared by this submission are: - Incorporation of optional internal PEEP control, replacing the optional external 록 mechanical PEEP valve used with the previously cleared LTV 1000 Ventilator. - 해 The addition of a Low PEEP alarm. - The addition of optional Patient Setting Control Presets to assist clinicians in initially setting patient ventilation set parameters. - I The addition of NPPV mode setting enhancements to assist the clinician in setting up NPPV mode ventilation. - I The addition of externally accessibility to the device internal battery for trained service personnel battery replacement. - g The designation of the modified LTV 1000 Ventilator as the VIASYS LTV 1200 Ventilator. (Note: The previously cleared Pulmonetic Systems LTV 1000 will continue to be marketed without the modifications listed in this submission). The LTV 1000 Ventilator, previously cleared for homecare, institutional and transport use is now being submitted for clearance with the listed modifications.

The LTV 1000 ventilator 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 adult and pediatric patients weighing at least 5 kg (11 lbs), who require the following types of ventilatory support: - Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask). . - Assist/Control, SIMV or CPAP modes of ventilation. . The ventilator is suitable for use in institutional, home, or transport settings.

The LTV 1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in institutional, home and transport settings, and is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support: - Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via . mask). - Assist/Control, SIMV, or CPAP modes of ventilation. . - Breath types including Volume, Pressure Control and Pressure Support. . The addition intended to be cleared by this submission is: - The addition of the Automobile Lighter Power Cord to be externally attached . to the LTV Series to power the LTV Ventilator while operating in an automobile. The power cord is designed to connect to +12V automobile cigarette lighter or auxiliary power outlets capable of supplying as least 20 amperes of current.

The LTV 1000 ventilator 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 adult and pediatric patients weighing at least 5 kg (11 lbs), who require the following types of ventilatory support: - Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via . mask). - Assist/Control, SIMV, or CPAP modes of ventilation. ● - Breath types including Volume, Pressure Control and Pressure Support. ● The ventilator is suitable for use in institutional, home, or transport settings.

The LTV 1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in institutional, home and transport settings, and is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support: - Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via . mask). - . Assist/Control, SIMV, or CPAP modes of ventilation. - Breath types including Volume, Pressure Control and Pressure Support. . The modification intended to be cleared by this submission is: - The addition of Spontaneous Breathing Trial (SBT) function allowing the clinician to . more easily determine a patient's ability to be weaned from ventilation.

The LTV 1000 ventilator 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 adult and pediatric patients weighing at least 5 kg (11lbs.), who require the following types of ventilatory support: - Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask). - Assist Control, SIMV, or CPAP modes of ventilation. - The ventilator is suitable for use in institutional, home, or transport settings.

The LTV 1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in institutional, home and transport settings, and is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support: - Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via . mask). - Assist/Control, SIMV, or CPAP modes of ventilation. . - Breath types including Volume, Pressure Control and Pressure Support. . The modification intended to be cleared by this submission is: The addition of commercially available heated wire breathing circuit inspiratory/expiratory limbs manufactured and distributed by Allegiance Healthcare Corporation (K000697), as an option to the ventilator breathing circuits specified for use

The LTV 1000 ventilator 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 adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support: - Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask). - Assist/Control, SIMV, or CPAP modes of ventilation. . - Breath types including Volume, Pressure Control and Pressure Support. . The ventilator is suitable for use in institutional, home and transport settings.

The LTV 1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in institutional, home and transport settings, and is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support: - . Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask). - Assist/Control, SIMV, or CPAP modes of ventilation. . - Breath types including Volume, Pressure Control and Pressure Support. ● The modifications intended to be cleared by this submission are: - . The addition of a High Breath Rate Alarm to alert operators to a patient's high breath rate condition. - . The addition of O2 cylinder duration monitoring to provide a reference indicator of the approximate remaining usable time of an external O2 cylinder based on operator entered input parameters. - The addition of a 100% O₂ flush feature allowing the operator to elevate delivered FIO₂ . for a preset time period. - The addition of Automatic High O₂ Switchover to alert operators that a high O₂ pressure . source is attached to the ventilator when a low O2 pressure source has been selected. In this condition, the ventilator will switch to a high O2 pressure source mode and set O2 delivery to 21% or room air. - A change in maximum allowable oxygen input pressure from 70 psig to allow . broader compatibility with institutional oxygen sources.

The LTV 1000 ventilator 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 adult and pediatric patients weighing at least 5 kg (11 lbs), who require the following types of ventilatory support: - Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask). - Assist/Control, SIMV, or CPAP modes of ventilation. The ventilator is suitable for use in institutional, home, or transport settings.

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