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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 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 Giraffe OmniBed Carestation is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the on user's demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperature-controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate's transition from the uterus to the external environment. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).

The Giraffe Incubator Carestation is an enclosed infant bed, which provides thermal support for infants who are unable to provide for their own heat requirements. The device maintains the infant's temperature by circulating heated air within the closed bed compartment. The operator may select either the air or skin temperature control method. Depending on the control method selected, heat is regulated based on either the air temperature or the infant's skin temperature compared to the operator selected control temperature. Physical access to the patient is obtained through the side portholes or by opening one of the side doors. The Giraffe Incubator Carestation has a color touchscreen user interface (UI) and includes a Hands-Free Alarm Silence (HFAS) feature. The incubator includes a mattress for patient comfort. The Giraffe Incubator Carestation incorporates an optional weighing scale, Servo O2, Uninterruptible Power Supply (UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storage drawers.

Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermoregulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. An optional integrated SpO2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate (measured by a SpO2 sensor). An optional integrated resuscitation system may be used to provide the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant.

The Panda iRes Warmer and Giraffe Warmer are infant radiant warmers with a heating source intended to maintain the thermal balance of an infant patient by direct radiation of energy in the infrared region of the electromagnetic spectrum. This device also provides optional integrated SpO2 Monitoring and Resuscitation. Radiant heat from an infrared heat source is focused onto the bed to warm the patient. The operator may select either the heater power or skin temperature control method. Depending on the control method selected, the heater is either regulated at the operator selected power level or the heater output is modulated to maintain the patient's temperature at the value selected by the operator. The subject devices have two control modes, Manual Mode and Baby Mode. In the manual Mode, the warmer controls radiant heater output from a heater power percentage setting that you enter using the control panel. In baby mode, the warmer controls radiant heater output based on temperature readings from a probe attached to the baby's skin (skin temperature probe and the reflective probe patch) and a set temperature (set temp) you enter using the control panel.

The HYDRO-TEMP Neonatal Skin Surface Temperature Sensor is a non-sterile device intended for connection to an infant radiant warmer to monitor the neonatal patient's skin surface temperature.

The HYDRO-TEMP Neonatal Skin Surface Temperature Sensor consists of a probe used to monitor a neonate's skin surface temperature used as an accessory while the patient is on an infant radiant warmer. The probe is a wire set with a thermistor chip at the distal end that passively modifies the electrical current traveling through the device. A colored connector at the proximal end of the wire set interfaces with the warming bed or a cable that interfaces with the bed. The probe is packaged with an adhesive pad used to affix the sensor to the patient's skin surface. The device is non-sterile and individually packaged in a resealable plastic bag.

The DeRoyal HYDRO-TEMP® Neonatal Skin Temperature Probe Covers are used to adhere the thermistor of the temperature probe to the patient and insulate the thermistor from ambient room temperature ensuring correct temperature readings.

The HYDRO-TEMP® Neonatal Skin Temperature Probe Cover is an accessory to be used with DeRoyal-branded NICU neonatal skin temperature probes used with an infant radiant warmer. They have not been evaluated for use with other manufacturer's products. It is an adhesive pad used to affix a temperature sensor to a neonate's skin to monitor the skin surface temperature. The cover also insulates the temperature sensor from ambient room temperature to ensure temperature readings are accurate. There are two configurations of the probe cover. Both of these configurations contain a release liner, a patient-contacting hydrogel adhesive, and a metallized polyester backing. One configuration contains an additional foam material that is placed in between the hydrogel adhesive and metallic backing. The device is non-sterile and can be packaged on its own in a foil pouch or in a resealable plastic bag with a temperature probe.

The NuBorne 500 Infant Warmer is an open care environment used for providing controlled infrared heat to neonates who are physiologically unable to maintain their body temperature or may require external heat to ease the transition from the mother's womb to the external environment. The device is intended to be used in a Labor & Delivery environment for infants immediately after birth, or in a Neonatal Intensive Care Unit for providing premature infants long duration therapy, or in newborn care areas, for providing external heat to low-birth weight infants, and for cases where clinical indications require short/ long duration warming therapy. The device allows access to the infants for various procedures, tilting of the infant and x-ray diagnostics. The device provides three modes of warming: Manual, Skin, and Standby mode for varying care requirements. Also, allows attaching optional accessories on the rail for therapy and monitoring of the infant.

The NuBorne Infant Warmer is an open care environment used for providing controlled infrared heat to neonates who are physiologically unable to maintain their body temperature or who need external heat to smoothen the transition from the mother's womb to the external environment. The NuBorne Infant Warmer has three modes of temperature control available – manual temperature mode, skin temperature control mode and standby mode. The device includes a bed that tilts, has height adjustment, side panels, APGAR timer, x-ray tray and an optional inbed scale.

Babyleo TN500 is intended for use with premature babies and can be used as both an incubator and a radiant warmer. When the product is switched between incubator and radiant warmer operation, patients continue to be kept warm during the transition. The device provides a thermally regulated environment for patients with a body weight of up to 5 kg (11 lbs) and a height of up to 55 cm (22 in). The device can be operated as either a closed care unit or an open care unit. As a closed care unit, Babyleo TN500 is an incubator.Neonates are kept warm in the patient with humidifiable air, which can be enriched with oxygen (option). As an open care unit, Babyleo TN500 is a radiant warmer. Babyleo TN500 provides controlled ambient conditions for premature babies and neonates. The following parameters are regulated, according to the intended use: - Temperature - Humidity - Oxygen (option)

The device Babyleo TN500 is a medical device used to maintain environmental conditions suitable for preterm babies and neonates. The important features are temperature and humidity. The operational principle is a combination of a neonatal incubator and an open warmer. Babyleo TN500 can be operated in closed care therapy as an incubator according to IEC60601-2-19 or in open care therapy as a warmer according to IEC60601-2-21. Additionally, an optional x-ray translucent heated mattress is intended to provide sensible heat to the preterm babies and neonates. The device consists of the following components: Incubator (=bassinet) with a convection heater and closed humidification system for the patient, trolley, radiant warmer, display, mattress, x-ray and height adjustment. Optional components are scale, heated mattress, drawer, oxygen regulation with cylinder holder and Auto Thermo package and Developmental Care package.

Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. An optional integrated SpO2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). An optional integrated resuscitation system may be used to provide the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant.

The Giraffe and Panda Warmers are devices with a radiant heating source intended to maintain the thermal balance of an infant patient by direct radiation of energy in the infrared region of the electromagnetic spectrum. The warmers operate similarly to warmers currently in use in hospitals. Radiant heat from an infrared heat source is focused onto the bed to warm the patient. The operator may select either the heater power or skin temperature control method. Depending on the control method selected, the heater is either regulated at the operator selected power level or the heater output is modulated to maintain the patient's temperature at the value selected by the operator. Infant radiant warmers are also used to provide thermal support during surgical procedures and during procedures such as extracorporeal membrane oxygenation, resuscitation, or other procedures requiring open access and thermal support. The units also feature optional integrated SpO2 and Resuscitation modules. The Resuscitation Module may feature either a traditional bag-and-mask technology or a T-piece technology. Both the SpO2 module and the Resuscitation Modules use existing technology. The Giraffe and Panda Warmers can be used with the Giraffe Shuttle and UPS, a mobile power source that allows for transport of the patient between care areas within the hospital building and provides power to the Warmers.

The Resuscitaire® Radiant Warmer is intended for thermoregulation, skin temperature monitoring, APGAR timing and resuscitation of newly born infants up to 10kg. It is not intended for long term resuscitation or home use.

The modified Resuscitaire Radiant Warmer is for newbom infants and consists of a bassinet, warmer and a controller module which provides heat control, monitoring of the skin temperature and an APGAR timer. It also includes optional manual and automated resuscitation with suction and oxygen delivery and a patient gas supply breathing circuit.