Search Results
Found 2 results
510(k) Data Aggregation
K Number
K213551Device Name
Giraffe Omnibed Carestation CS1
Manufacturer
Datex Ohmeda Inc.
Date Cleared
2022-03-02
(114 days)
Product Code
FMT, FMZ
Regulation Number
880.5130Why did this record match?
Applicant Name (Manufacturer) :
Datex Ohmeda Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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%).
Device Description
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.
Ask a Question
K Number
K213553Device Name
Giraffe Incubator Carestation CS1
Manufacturer
Datex Ohmeda Inc.
Date Cleared
2022-03-02
(114 days)
Product Code
FMZ
Regulation Number
880.5400Why did this record match?
Applicant Name (Manufacturer) :
Datex Ohmeda Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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%).
Device Description
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.
Ask a Question
Page 1 of 1