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The Babyroo TN300 is an open care radiant warmer that provides a controlled source of heat and regulation of skin temperature for neonates and infants. The optional integrated resuscitation module provides emergency respiratory support administered by clinicians and includes the functionality of suction. Additionally, the device provides weighing (optional) and pulse oximetry (optional) of neonates and infants. The device is designed for use with a body weight up to 10 kg (22 lb). The device is indicated for thermoregulation, skin temperature regulation, weighing (optional), pulse oximetry (optional), and resuscitation (optional) of neonates and infants.

The purpose of this premarket notification is to activate, for the US market, existing optional functionality which enables the display of SpO2 information by the subject Babyroo TN300 via its graphical user interface (GUI). The SpO2 display functionality is facilitated through connection with existing, cleared pulse oximetry accessories which generate the SpO2 information that is displayed on the subject Babyroo TN300 GUI. As originally cleared under K230278: The Babyroo TN300 is an open care infant radiant warmer that provides controlled source heat and skin temperature display for use with neonates and infants. The device can be configured for either labor and delivery or the newborn intensive care unit (NICU) and can be used for intra hospital transfer. Warming therapy is interrupted during intra hospital transfer and patient is not supplied with heat. The Babyroo TN300 device is offered with a fixed height or adjustable height trolley configuration and provides two heat sources for infant warming: a radiant warmer and an optional heating plate with conductive gel mattress. The device's bed can be tilted up to 15° in Trendelenburg and reverse Trendelenburg directions and the design of the device is intended to facilitate uniform heat distribution over the entire mattress surface across the range of bed tilt angulation. An optional removable canopy is available for intra-hospital transfer. Infant warming is facilitated via three (3) available thermorequlation modes: - Manual mode - Skin temperature mode - Kangaroo mode The Babyroo TN300 is available with an optional Resuscitation module. The optional Resuscitation module is pneumatically powered, can be connected to central gas supplies or gas cylinders, and provides emergency resuscitation and suction to the patient. The optional Resuscitation module includes adjustment for gas flow, peak inspiratory pressure, O2 concentration, and suction functionality and is available in three (3) variants: - Resuscitation module with gas mixer and AutoBreath®. - Resuscitation module with gas mixer. - Resuscitation with O2 only. The optional AutoBreath® function facilitates pneumatically driven, automatic respiratory rate and positive end-expiratory pressure control. The Babyroo TN300 can be configured to include an optional integrated electronic scale, as well as, optional heated gel mattress, optional integrated single or dual storage drawers, optional gas cylinder holders, and optional x-ray tray.

The Infinity CentralStation (ICS) is intended for use by trained health care professionals for the purpose of centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of data from networked patient monitors including the annunciation of visual and audible physiologic parameter alarms at a central monitoring workstation. Infinity CentralStation with Rest ECG is intended for the production and interpretation of diagnostic electrocardiograms for adult and pediatric patients when connected to a monitor with diagnostic 12-Lead ECG monitoring enabled.

The Infinity® CentralStation (ICS) Wide (or widescreen) is a Central monitoring station capable of real-time display and storage of multi-parameter physiological patient data and alarm annunciation for networked devices including but not limited to ambulatory and non-ambulatory wireless telemetry monitoring.

The Infinity Gateway software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.

The Infinity Gateway Suite is a suite of software applications that are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network. Infinity Gateway Suite is designed to support the unique needs of hospitals, and provide a complete range of options for information connectivity, including: - Server Software Health Level seven (HL7) Interface Software Options - - -American society for testing and materials (ASTM) Stat Lab interface - -Developer Tools - Pager Interface - - -Alarm history database - -Time master functions - -12-lead electrocardiogram (ECG) export Infinity Gateway Suite is designed as a client-server application that provides a way for users to view patient information on a hospital workstation that is connected via the hospital network. The server portion runs on a Windows server that is connected directly to the hospital Local Area Network (LAN) and to the Infinity Network. Data access methods are available as options that customers can purchase and enable independently once they install the basic Infinity Gateway application. The Infinity Gateway Suite facilitates the exchange of important clinical information between the Infinity protocol and existing hospital and patient care systems. The Infinity Gateway Suite is designed to provide flexibility by using common healthcare protocols and data format standards for managing communications between multiple disparate systems. The user may select one or more Infinity Gateway Developer Tools and/or Interface Options to create a seamless flow of information tailored to support clinical workflow. Infinity Gateway Developer Tools and Interface Options are licensed or unlocked by using option passwords associated with a dongle. An option password is the electronic proof of purchase for the Infinity Gateway software. During the at-hospital setup procedure, the user will be asked for an option or license password which is a unique number associated with the licensing dongle issued. The licenses are always associated with the physical dongle. The Infinity Gateway Developer Tools (such as WinAccess API) enable the development of custom applications to support customers' homegrown applications to support clinical research projects or downstream information systems. Finally, Infinity Gateway provides flexible deployment opportunities by leveraging the virtual machine technology, which facilitates software deployments. Infinity Gateway also promotes patient safety with efficient workflows for timely decisionmaking by integrating patient data and providing continuity-of-care support. Furthermore, it makes comprehensive clinical data available at the point-of-care by facilitating the exchange of lab reports and admission information between the Infinity Network and other hospital systems. The subject device is compatible with Infinity Central Station Wide version VG5.0

The Infinity CentralStation (ICS) is intended for use by trained healthcare professionals for the purpose of centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of data from networked patient monitors including the annunciation of visual and audible physiologic parameter alarms at a central monitoring workstation. Infinity CentralStation with Rest ECG is intended for the production of diagnostic electrocardiograms for adult and pediatric patients when connected to a monitor with diagnostic 12-Lead ECG monitoring enabled. The Infinity M300/M300+ is intended for use with the ICS to monitor ECG and pulse oximetry and nonambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network. The Infinity M300/M300+ with TruST is intended for 12-Lead ECG monitoring with a reduced set of electrodes. Reconstructed leads are intended for real-time assessment of ST segment changes.

The Infinity® CentralStation (ICS) Wide (or widescreen) is a Central monitoring station capable of real-time display and storage of multi-parameter physiological patient data and alarm annunciation for networked devices including but not limited to ambulatory and non-ambulatory wireless telemetry monitoring. The Infinity M300/M300+ is a wireless telemetry, patient-worn device with rechargeable lithiumion battery which monitors ECG and SpO2 physiological data and features a color display, local alarm alerts and keypad interface. ECG functions include heart rate, arrhythmia detection and ST segment analysis and SpO2 functions include pulse plethysmogram and pulse rate. Infinity M300/M300+ with TruST allows for 12-lead ECG monitoring with a reduced set of electrodes by deriving values for missing leads.

The Babyroo TN300 is an open care radiant warmer that provides a controlled source of heat and regulation of skin temperature for neonates and infants. The optional integrated resuscitation module provides emergency respiratory support administered by clinicians and includes the functionality of suction. Additionally, the device provides weighing (optional) of neonates and infants. The device is designed for use with a body weight up to 10 kg (22 lb). The device is indicated for thermoregulation, skin temperature regulation, weighing (optional), and resuscitation (optional) of neonates and infants.

The Babyroo TN300 is an open care infant radiant warmer that provides controlled source heat and skin temperature display for use with neonates and infants. The device can be configured for either labor and delivery or the newborn intensive care unit (NICU) and can be used for intra hospital transfer. Warming therapy is interrupted during intra hospital transfer and patient is not supplied with heat. The Babyroo TN300 device is offered with a fixed height or adjustable height trolley configuration and provides two heat sources for infant warming: a radiant warmer and an optional heating plate with conductive gel mattress. The device's bed can be tilted up to 15° in Trendelenburg and reverse Trendelenburg directions and the design of the device is intended to facilitate uniform heat distribution over the entire mattress surface across the range of bed tilt angulation. An optional removable canopy is available for intra-hospital transfer. Infant warming is facilitated via three (3) available thermoregulation modes: - Manual mode - Skin temperature mode - Kangaroo mode The Babyroo TN300 is available with an optional Resuscitation module. The optional Resuscitation module is pneumatic powered, can be connected to central gas supplies or gas cylinders and provides emergency resuscitation and suction to the patient. The optional Resuscitation module includes adjustment for gas flow, peak inspiratory pressure, O2 concentration, and suction functionality and is available in three (3) variants: - Resuscitation module with gas mixer and AutoBreath®. - Resuscitation module with gas mixer. - Resuscitation with O2 only. The optional AutoBreath® function facilitates pneumatically-driven, automatic respiratory rate and positive end-expiratory pressure control. The Babyroo TN300 can be configured to include an optional integrated electronic scale, as well as, optional heated gel mattress, optional integrated single or dual storage drawers, optional gas cylinder holders, and optional x-ray tray. The Babyroo TN300 device has an expected service life of 10 years.

The Infinity Gateway software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.

The Infinity Gateway Suite is a suite of software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network. Infinity Gateway Suite is designed to support the unique needs of hospitals, and provide a complete range of options for information connectivity, including: - Server Software Health Level seven (HL7) Interface Software Options - - -American society for testing and materials (ASTM) Stat Lab interface - -Developer's Tools - -Remote View Applications - । Pager Interface - -Alarm history database - -Time master functions - -12-lead electrocardiogram (ECG) export - Service-Oriented Device Compatibility (SDC) interface with encryption - Infinity Gateway is designed as a client-server application that provides a way for users to view patient information on a hospital workstation that is connected via the hospital network. The server portion runs on a Windows server that is connected directly to the hospital Local Area Network (LAN) and to the Infinity Network. Data access methods are available as options that customers can purchase and enable independently once they install the basic Infinity Gateway application. The Infinity Gateway Server facilitates the exchange of important clinical information between the Infinity/SDC protocol and existing hospital and patient care systems. The Infinity Gateway Server is designed to provide flexibility by using common healthcare protocols and data format standards for managing communications between multiple disparate systems. The user may select one or more Infinity Gateway Developer's Tools and Interface Options to create a seamless flow of information tailored to support clinical work flow. Infinity Gateway Developer's Tools and Interface Options are licensed or "unlocked" by using option passwords that are associated with a USB license dongle. An option password is the electronic proof of purchase for the Infinity Gateway software. During the at-hospital setup procedure, the user will be asked for an option or license password which is a unique number associated with the licensing dongle issued. The licenses are always associated with the physical dongle. The Infinity Gateway developer's tools (such as WinAccess API) enable the development of custom applications to support customers' homegrown applications to support clinical research projects or downstream information systems. Finally, Infinity Gateway provides flexible deployment opportunities by leveraging the virtual machine technology, which facilitates cost-effective software deployments and reduces the total cost of ownership. Infinity Gateway also promotes patient safety with efficient workflows for timely decisionmaking by integrating patient data and providing continuity-of-care support. Furthermore, it makes comprehensive clinical data available at the point-of-care by facilitating the exchange of lab reports and admission information between the Draeger Infinity Network and other hospital systems.

Intended Use Infinity® Acute Care System™ (IACS) The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric, and neonatal patients in environments where patient care is provided by trained health care professionals. The IACS obtains the physiologic, multi-parameter data from the M540 monitor and optional medical devices and displays. The real-time physiologic and multi-parameter data collected from the IACS is made available on the Infinity network. The IACS and optional connected hardware are not intended for use in the following hospital environments: - Hyperbaric chambers - Environments containing MRI equipment Indications for use The IACS, in connection with the M540 Patient Monitors the following parameters: - Heart rate - Arrhythmia (adult and pediatric patients only) - 12-lead Rest ECG analysis (adult and pediatric patients only) - ST segment analysis including TruST (adult and pediatric patients only) - Apnea - Impedance respiratory rate RRi - Invasive blood pressure IBP - Non-invasive blood pressure NIBP - Temperature - Cardiac output (adult and pediatric patients only) - Carbon dioxide etCO2, inCO2, RRc - Arterial oxygen saturation SpO2 - Pulse rate - Perfusion index PI - Total hemoglobin SpHb, (adult and pediatric patients only) - Total oxygen content SpOC, (adult and pediatric patients only) - Carboxyhemoglobin saturation SpCO (adult and pediatric patients only) - Methemoglobin saturation SpMet - Pleth variability index PVI The IACS can connect to third-party devices to display physiologic, multi-parameter data and stored trends. It can also send information across the Infinity network. Intended Use The Infinity 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. Indications for Use As the Infinity Medical Cockpits are used in conjunction with the Infinity Acute Care System and the M540 Patient Monitors they do not have their own indication for use. Intended Use The Infinity M540 (M540) is intended for the monitoring of multi-parameter, physiologic patient monitoring of adult, pediatric, and neonatal patient information in environments where patient care is provided by trained health care professionals. The M540 obtains physiological data from connection to optional accessory devices. The real-time physiologic and multiparameter data collected from the M540 is made available on the Infinity network. The M540 is intended to monitor one patient at a time. The M540 and any connected hardware are not intended for use in the following hospital environments: - Hyperbaric chambers - Environments containing MRI equipment Indications for use The M540 monitors the following parameters: - Heart rate - Arrhythmia (adult and pediatric patients only) - 12-lead Rest ECG analysis (adult and pediatric patients only) - ST segment analysis including TruST (adult and pediatric patients only) - Apnea - Impedance respiratory rate RRi - Invasive blood pressure IBP - Non-invasive blood pressure NIBP - Temperature - Cardiac output only available when the M540 is docked in an IACS configuration (adult and pediatric patients only) - Carbon dioxide etCO2, inCO2, RRc - Arterial oxygen saturation SpO2 - Pulse rate - Perfusion index PI - Total hemoglobin SpHb, (adult and pediatric patients only) - Total oxygen content SpOC, (adult and pediatric patients only) - Carboxyhemoglobin saturation SpCO (adult and pediatric patients only) - Methemoglobin saturation SpMet - Pleth variability index PVI

The Infinity® Acute Care System™ (IACS) Monitoring Solution is a multi-parameter physiological patient monitoring system that acquires and displays patient data at the bedside. The IACS is a combination of the following devices: Infinity M540 Patient Monitor (Model #MS20401) with the Infinity M500 Docking Station (Model #MS20407) integrated with the Infinity Medical Cockpit (Model #MK31501 - 17" screen or Model MK31701 - 21" screen) and respective software, powered by the Infinity P2500 power supply (Model #MS22277). The physiological patient data acquired from the interconnected components is displayed on the Infinity M540 Patient Monitor and is transmitted via network to the patient bedside Infinity Medical Cockpit. The Infinity M540 Patient Monitor is a lightweight hand-held patient monitor that displays real-time vital signs, provides continuous trending and produces visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and transmits the data over the network. The Infinity M540 Patient Monitor can be used as a stand-alone medical device without integration with the Infinity Medical Cockpits. Associated accessories may include: - Infinity MCable Masimo SET Model #MS20667 - Infinity MCable Masimo SET Rainbow Model #MS27900 / MS27003 - Infinity MCable – Nellcor OxiMax – Model #MS20668 - Infinity MPod Quad Hemo Model #MS20725 - Infinity MCable Dual Hemo Model #MS20783 - Infinity MCable Mainstream CO2 Model #6871950 - Infinity MCable - Analog/Sync - Model #MS20662 - Infinity MCable – Nurse Call – Model #8417370 - PS120 Desktop Power Supply - Model #2606270 - Y-Adapter (for PS120) Model #MS29702 The IACS, Monitoring Solution is a software driven device that is supplied and used non-sterile in a hospital environment by trained personnel. The IACS, Monitoring Solution is capital equipment.

Intended Use Infinity® Acute Care System™ (IACS) The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric, and neonatal patients in environments where patient care is provided by trained health care professionals. The IACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The real-time physiologic and multi-parameter data collected from the IACS is made available on the Infinity network. The IACS and optional connected hardware are not intended for use in the following hospital environments: - Hyperbaric chambers - Environments containing MRI equipment Indications for Use The IACS, in connection with the M540 Patient Monitor, monitors the following parameters: - Heart rate - Arrhythmia (adult and pediatric patients only) - 12-lead Rest ECG analysis (adult and pediatric patients only) - ST segment analysis including TruST (adult and pediatric patients only) - Apnea - Impedance respiratory rate RRi - Invasive blood pressure IBP - Non-invasive blood pressure NIBP - Temperature - Cardiac output (adult and pediatric patients only) - Carbon dioxide etCO2, inCO2, RRc - Arterial oxygen saturation SpO2 - Pulse rate - Perfusion index PI - Total hemoglobin SpHb, (adult and pediatric patients only) - Total oxygen content SpOC, (adult and pediatric patients only) - Carboxyhemoglobin saturation SpCO (adult and pediatric patients only) - Methemoglobin saturation SpMet - Pleth variability index PVI The IACS can connect to third-party devices to display physiologic, multi-parameter data and stored trends. It can also send information across the Infinity network. Intended Use The Infinity 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. Indications for Use As the Infinity Medical Cockpits are used in conjunction with the Infinity Acute Care System and the M540 Patient Monitors they do not have their own indication for use. Intended Use The Infinity M540 (M540) is intended for the monitoring of multi-parameter, physiologic patient monitoring of adult, pediatric, and neonatal patient in environments where patient care is provided by trained health care professionals. The M540 obtains physiological data from connection to optional accessory devices. The real-time physiologic and multi-parameter data collected from the M540 is made available on the Infinity network. The M540 is intended to monitor one patient at a time. The M540 and any connected hardware are not intended for use in the following hospital environments: - Hyperbaric chambers - Environments containing MRI equipment Indications for Use The M540 monitors the following parameters: - Heart rate - Arrhythmia (adult and pediatric patients only) - 12-lead Rest ECG analysis (adult and pediatric patients only) - ST segment analysis including TruST (adult and pediatric patients only) - Apnea - Impedance respiratory rate RRi - Invasive blood pressure IBP - Non-invasive blood pressure NIBP - Temperature - Cardiac output - only available when the M540 is docked in an IACS configuration (adult and pediatric patients only) - Carbon dioxide etCO2, inCO2, RRc - Arterial oxygen saturation SpO2 - Pulse rate - Perfusion index PI - Total hemoglobin SpHb, (adult and pediatric patients only) - Total oxygen content SpOC, (adult and pediatric patients only) - Carboxyhemoglobin saturation SpCO (adult and pediatric patients only) - Methemoglobin saturation SpMet - Pleth variability index PVI

The Infinity® Acute Care System™ (IACS) Monitoring Solution is a multi-parameter physiological patient monitoring system that acquires and displays patient data at the bedside. The IACS is a combination of the following devices Infinity M540 Patient Monitor (Model # MS20401) with the Infinity M500 Docking Station (Model #MS20407) integrated with the Infinity Medical Cockpit (Model # MK31501 - 17" screen or MK31701 - 21" screen) and respective software, powered by the Infinity P2500 power supply (Model #MS22277). The physiological patient data acquired from the interconnected components is displayed on the Infinity M540 Patient Monitor and is transmitted via network to the patient bedside Infinity Medical Cockpit. The Infinity M540 Patient Monitor is a lightweight hand-held portable patient monitor that displays real-time vital signs, provides continuous trending and produces visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and transmits the data over the network. The Infinity M540 Patient Monitor can be used as a stand-alone medical device without any integration with the Infinity Medical Cockpit. Associated accessories may include: - · Infinity MCable Masimo SET Model #MS20667 - •Infinity MCable Masimo SET Rainbow Model #MS27900 / MS27003 - ·Infinity MCable Nellcor OxiMax Model #MS20668 - · Infinity MPod Quad Hemo Model #MS20725 - •Infinity MCable Dual Hemo Model #MS20783 - •Infinity MCable Mainstream CO2 Model #6871950 - ●Infinity MCable Analog/Sync Model #MS20662 - •Infinity MCable Nurse Call Model #8417370 - •PS120 Desktop Power Supply Model #2606270 - •Y-Adapter (for PS120) Model #MS29702 The IACS, Monitoring Solution is a software driven device that is supplied and used non-sterile in a hospital environment by trained personnel. The IACS, Monitoring Solution is capital equipment.

The Infinity M300 is intended for use with the ICS to monitor ECG and pulse oximetry on ambulatory and nonambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network. The Infinity M300 with TruST is intended for 12-Lead ECG monitoring with a reduced set of electrodes. Reconstructed leads are intended for real-time assessment of ST segment changes.

The Infinity M300 is a wireless telemetry, patient-worn device with rechargeable lithium-ion battery which monitors ECG and SpO2 physiological data and features a color display, local alarm alerts and keypad interface. ECG functions include heart rate, arrhythmia detection and ST segment analysis and SpO2 functions include pulse plethysmogram and pulse rate. Infinity M300 with TruST allows for 12-lead ECG monitoring with a reduced set of electrodes by deriving values for missing leads.

The Isolette® 8000 plus is indicated for thermoregulation and controlling oxygen (optional), and humidity (optional) for both premature and full-term infants up to a maximum of 10 kg (22lbs). The Isolette® 8000 plus is not intended for home use.

The Isolette® 8000 plus is a neonatal incubator that provides a controlled environment for both premature and full-term infants up to a maximum of 10 kg (22lbs). It controls temperature, oxygen and humidity (both are optional). The predicate device as cleared in K172154 is offered with the hood and shell assembly of the incubator mounted on a variable high adjustable (VHA) trolley. All components and accessories for the device were cleared as part of the system. The modification of the device is the replacement of the variable height adjustable (VHA) trolley with a fixed-height cabinet stand trolley. All other components and accessories of the device are identical to those cleared under K172154. The modification does not change the intended use or alter the fundamental scientific technology of the currently approved predicate device.