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The Giraffe Incubator Carestation is an Infant Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. They achieve this by providing an enclosed temperature controlled environment to the infant. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%). 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 other 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 OmniBed Carestation is a device that can function as an incubator (in the closed mode) or as an infant radiant warmer (in the open mode) based on the user's selection. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. In the closed bed mode of operation, the bed functions as an incubator, maintaining the infant's temperature by circulating heated air within the enclosed bed compartment. Warm air is circulated through the closed patient 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 operated selected control temperature. Physical access to the patient is obtained through the side portholes or by opening one of the side doors. In the open bed mode, this bed operates like a conventional open, radiantly heated infant bed. Radiant heat from an infrared heat source is focused onto the bed to warm the patient. The Giraffe OmniBed Carestation incorporates an optional weighing scale, Servo O2, Uninterruptible Power Supply (UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storage drawers.

The device is an infant incubator and an infant warmer. The two functions can be converted through the canopy lifting system. The incubator provides an enclosed, temperature-controlled environment and the warmer provides infrared heat in an open environment. The warmer provides heat in a controlled manner to neonates who are unable to thermoregulate based on their own physiology. The incubator and warmer may also be used for short periods of time to facilitate a neonate's transition from the uterus to the external environment.

The YP-3000 has the functions of an infant incubator and an infant radiant warmer. The infant radiant warmer is optional, the two functions can be converted through the canopy lifting system. For the infant incubator, the temperature control system implements servo control on the temperature in the incubator (air temperature / skin temperature) and the device performs proportional heating control based on the setting of the temperature and the actual measured temperature. The internal air is adjusted through thermal convection to create an environment with proper temperature and humidity for infant incubation. It is intended to be used for constant temperature incubation of low birth weight infants, critically sick babies and neonates, as well as neonatal body temperature resuscitation, transfusion, oxygen therapy, emergency treatment, and hospitalization for neonates. The Infant radiant warmer transfers heat to the patient from the infrared radiation heating source through the parabolic reflecting hood transmitting heat to the patient on the mattress. proportional heating is controlled based on actual skin temperature. The device is equipped with a mattress, an electronic scale, and an oxygen control system. Other accessories include an observation lamp, tray, and an IV pole.

Babyleo TN500 is intended for use with premature babies and neonates 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 requlated 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 compartment 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 tray and height adjustment. Optional components are scale, heated mattress, drawer, oxygen regulation with cylinder holder and Auto Thermo package and Developmental Care package. The subject of this submission is the addition of the optional Touch time function, which can be activated in order to stabilize the thermal environment in the patient compartment when the hand ports are opened. It supports users during routine tasks (e.g. changing diapers, washing the baby, checking sensors). Additionally, the scale resolution is changed from 5q to 10g.

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.

The Isolette® 8000 plus incubator 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 device used to maintain environmental conditions suitable for neonates. The Isolette 8000 plus incubator provides a controlled environment for both premature and full-term infants up to a maximum of 10 kg (22lbs). It controls temperature, oxygen (optional) and humidity (optional). It is a controller-based incubator featuring the ability to enable simultaneous control of temperature, and optional oxygen and humidity. The system operates on AC power. Data is provided on a liquid crystal display. It is operated in closed care therapy as an incubator according to IEC60601-2-19. Components include hand ports or iris ports, access panel, serial port, trolley with height adjustment, castor wheels with brakes, power receptacle, a Trendelenburg bed-tilt mechanism (0° to 12°), softbed mattress, skin temperature probes, probe covers, oxygen inlet, sensor module, hose grommets, accessoryrail and cable wrap. Optional components include IV pole, drawers, water reservoir, collection bottler mount litter bag holder, basket for gloves, breathing hose holder kit, tray, high frequency ventilation (HFV) door with grommets, positioning aids, incubator cover, and monitor shelf.

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.

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 other 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 OmniBed Carestation is an updated version of the cleared predicate Giraffe OmniBed. The Giraffe OmniBed Carestation is a combination device that can function as an incubator (with the canopy closed) or as an infant radiant warmer (with the canopy open) based on the user's selection. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. With the canopy closed, the bed functions as an incubator, maintaining the infant's temperature by circulating heated air within the enclosed 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 operated selected control temperature. Physical access to the patient is obtained through the side portholes or by opening one of the side doors. With the canopy opened, this bed operates like a conventional open, radiantly heated infant bed. Radiant heat from an infrared heat source is focused onto the bed to warm the patient. The Giraffe OmniBed Carestation incorporates an optional weighing scale, Uninterruptible Power Supply (UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storage drawers. The proposed modification of the Giraffe OmniBed is referred to as the Giraffe OmniBed Carestation. The Giraffe OmniBed Carestation updates the graphical monochrome display user interface (UI) on the predicate to a digital touchscreen UI, with the required software changes to support the new format and layout. The main system control software was not changed; however the software for the UI was updated because of the UI format change. The modified Giraffe OmniBed Carestation maintains the predicate Giraffe OmniBed functionality, performance, and clinical workflows. The changes also include a modified device visual indicator light and the capability for Hands Free Alarm Silencing (HFAS). Other modifications being made for the Giraffe OmniBed Carestation include upgrading the power supply from 75W to 120W to support the increased power requirements of the touchscreen and associated electronics. There is no change in the indications for use or intended use of the system. There are no changes to the patient contacting materials of the device, and they remain identical to the predicate. The changes made do not affect the function, performance, safety, or clinical use of the device.

The Giraffe Incubator Carestation is an Infant Incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. They achieve this by providing an enclosed temperature controlled environment to the infant. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).

The Giraffe Incubator Carestation is an updated version of the cleared predicate Giraffe Incubator. 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 incorporates an optional weighing scale, Uninterruptible Power Supply (UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storage drawers.

Bisto's BT-500 is a Infant Incubator and intended to keep Premature in a warm environment in the hood for Neonatal hypothermia, Observation and Examination in newborn nurseries. BT-500 provides Heat and Air in a controlled manner to neonates or premature infants who are unable to themn-regulate on their own physiology. BT-500 is not intended for transport.

BT-500 Infant Incubator consists of Hood, Control Box, LCD external monitor and main body with stand ( optional), This device incorporates two sensors to control Humidity, and Temperature inside the Hood and monitors the Air Conditions, and controls Circulation with proper temperature. Also Heater is equipped inside of the hood to control the Skin Temperature of Infant at a fixed level as measured by the skin probe and showing, measuring and graphing the humidity, Air Temperature, Skin Temperature, Weight and SpO2 This Incubator is provided with function to control the infant's skin temperature.

The Dual Incu i is a combination of an infant incubator and an infant warmer. The device can transition from one mode to the other on user's demand. The Dual Incu i is an incubator for newborns and premature neonates. It is mainly intended for temperature control in neonatal hypothermia, observation and examination in newborn nurseries, prevention of body temperature drop shortly after delivery, and pre-operative and post-operative intensive care in neonatal surgery. This incubator is provided with a function to control the infant's skin temperature. Optional functions include pulse oximetry and oxygen density controlling.

Dual Incu i (Atom Infant Incubator Model 100) is a combination of an infant incubator and an infant warmer. This device consists of hood, a main body, a control panel and a warming heater (radiant warmer) and a stand with casters. A hood consists of a canopy and access doors (snapopen access port). An Oxygen sensor, a humidity sensor and a temperature sensor which monitor the air conditions inside the hood, are connected to the sensor module. A main body consists of a mattress, a mattress platform, a conditioning chamber, a humidity chamber. A control panel and skin temperature sensors are connected to the main body. This device has a function that elevates the canopy. The device operates as an incubator when the canopy is closed, and the device operates as a radiant warmer when the canopy is opened. This product has 2 types of function modes; one is "servo control mode" (called as "skin temperature control mode" also) and another is "manual control mode". When the device is operated as an incubator, skin temperature can be set from 34° to 38° (including override) in "servo control mode", and air temperature inside the hood can be set from 23 ° to 39 ° (including override) in "manual control mode". When the device is operated as an infant warmer, skin temperature can be set from 34° to 38° (including override) also in "servo control mode", and heater output of the warming heater can be set from 0 to 100%(in 5% increments) in "manual control mode". In "servo control mode", baby's skin temperature is monitored by temperature sensor attached on baby's body, and baby's skin temperature is controlled according to difference between monitored baby's skin temperature and set skin temperature. In "manual control mode", air temperature inside the hood is monitored by temperature sensor of sensor module, and air temperature inside the hood is controlled according to difference between monitored air temperature inside the hood and set air temperature, when the device is operated as an incubator. The mattress platform can be tilted. X-ray cassette tray is installed under the mattress platform. The device has 6 kinds of accessories: "Skin temperature sensor", "Oxygen sensor", "Piping hose for oxygen", "Electrostatics air filter", "Access port cover" and "Oxygen calibration tool", and these 6 accessories are available separately as replacements. "SpO2 Module", "Oxygen Controller", "Weight Monitor" and "Humidifier Chamber" are components of this device, and it is optional whether they are initial attached initially or not. If they are not attached initially, they can be attached later, and then SpO2/pulse monitoring, oxygen density controlling, weight monitoring and humidifying function can be available. The 4 kinds of components can be supplied individually. The stand can go up and down.