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The Infinity Acute Care System Workstations Neonatal Care consist of monitoring and control displays and additional therapy units. They are intended to be used as integrated, networked, and configurable workstations to provide specific therapy in neonatal intensive care. The Infinity Acute Care System Workstations Neonatal Care are intended to be used by qualified and trained medical personnel. The Infinity C Series Medical Cockpits, consisting of the C500 and the C700, are monitoring and control displays for the Infinity Acute Care System (IACS). Medical Cockpits are intended to be used to monitor waveforms, parameter information, and alarms as well as to control settings. The Infinity Series Medical Cockpits are intended to be used in environments where patient care is provided by trained healthcare professionals. The Babylog VN500 ventilation unit of the Infinity Acute Care System is intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Babylog VN500 offers mandatory ventilation modes for spontaneous breathing support and airway monitoring. The Babylog VN500 ventilation unit is used with Infinity C Series Dräger Medical Cockpits. The Babylog VN500 ventilation unit is intended for use in different medical care areas. Babylog VN500 is intended for stationary use in hospitals and medical rooms or for patient transportation within the hospital.

The Infinity Acute Care System Workstation Neonatal Care provides Neonatal-Care specific functionality. It is made up of the ventilation unit Babylog VN500 and the Infinity Medical Cockpit C500. The ventilation unit provides Neonatal-Care specific ventilation and monitoring data of ventilation parameters. The Infinity Medical Cockpit C500 is the control and display unit which runs a ventilation application. The patient monitoring data are displayed on the Infinity Medical Cockpit C500, which is also used to control ventilation settings including alarms. The ventilation unit Babylog VN500 of the Infinity Acute Care System Workstation Neonatal Care is a microprocessor-controlled ventilator. The Babylog VN500 provides overpressure ventilation and adjustable oxygen concentration with pressure- and volume-controlled automatic and spontaneous breathing modes. The ventilation application software on the Infinity Medical Cockpit C500 is needed to allow the user to display and control all ventilation parameters of the ventilation unit. The combination of the ventilation software application on the Infinity Medical Cockpit C500, together with the Babylog VN500, provides the functionality of a complete ventilator (e.g. Evita XL). The ventilation application supports simultaneous display of patient waveforms, parameter data, alarm display and annunciation, in addition to supporting graphical or textual display of historical data. The Infinity Acute Care System can interface with specific Dräger Medical therapeutic and diagnostic equipment, as well as third party devices via a MEDIBUS data connection. The user interface of the Infinity Acute Care System Workstation Neonatal Care is the Infinity Medical Cockpit C500, a standardized display and control unit for the connected monitoring and therapy units. The Infinity Medical Cockpit C500 is a standard platform, using common hardware, software, and user interface components to facilitate ease of use for clinicians.

The EvitaXL is a long-term ventilator for intensive care for adults, children, and infants with a body weight of at least 3 kg (6.6 lbs). With SmartCare™/PS the EvitaXL is intended to stabilize the patient's spontaneous breathing in a "comfortable zone" and to reduce inspiratory support for adults and children with a body weight of at least 15 kg (33 lbs). The patients should be haemodynamically stable with adequate oxygenation and spontaneous breathing. SmartCare can be used for intubated or tracheotomized patients. Patients with body weight between 15 and 35 kq (33.1 and 77.8 lbs) must be endotracheally intubated and ventilated with active humidification. SmartCare™/PS is contraindicated in case of severe COPD and severe neurologic disorder that affects the cerebral control mechanism of the spontaneous breathing pattern.

The EvitaXL is a time-cycled microprocessor-controlled intensive care ventilator. The option SmartCare™ for the EvitaXL has been developed for assisting physicians and respiratory therapists with the standardization of the weaning process used in intensive care units. The system uses a computerbased representation of a protocol and focusses on the management of pressure support. Scope of this submission is an extension of claims made in the promotional material, while the itself remains unchanged except for minor modifications that led to non-filing decisions for use, the intended use and the instructions for use also remain unchanged.

The EvitaXL is a long-term ventilator for intensive care for adults, children, and infants with a body weight of at least 3 kg (6.6 lbs). With SmartCare™/PS the EvitaXL is intended to stabilize the patient's spontaneous breathing in a "comfortable zone" and to reduce inspiratory support for adults and children with a body weight of at least 15 kg (33 lbs). The patients should be haemodynamically stable with adequate oxygenation and spontaneous breathing. SmartCare can be used for intubated or tracheotomized patients. Patients must be endotracheally intubated and ventilated with active humidification. SmartCare™/PS is contraindicated in case of severe COPD and severe neurologic disorder that effects the cerebral control mechanism of the spontaneous breathing pattern.

The EvitaXL is a time-cycled microprocessor-controlled intensive care ventilator. For the EvitaXL a new system called SmartCare™ has been developed for assisting physicians and respiratory therapists with the standardization of the weaning process used in intensive care units. The system uses a strategy that gradually reduces the level of assistance, at a rate that is guided by a patient's tolerance, while measuring his/her capacity to breathe without mechanical assistance. The SmartCare / PS system refers to measured patient data and adjusts the pressure support provided by EvitaXL for intubated or tracheotomized patients. SmartCare / PS essentially uses three parameters measured by EvitaXL: respiratory rate, tidal volume, and expiratory CO2 concentration. It controls the level of pressure (PSupp. above PEEP) during ventilation in CPAP/PS mode. SmartCare / PS has three main functions: automatic adaptation of ventilatory assistance, automatic weaning strategy, automation of the weaning test. Physically, the SmartCare / PS system has been accomplished by adding a printed circuit board and software.