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The Embryo Real-time Incubator (TLS301) is intended to provide an environment with controlled temperature and mixed gas (CO2 and other gases) for the development of embryos. The Embryo Real-time Incubator (TLS301) has an integrated camera and optics for imaging and viewing embryos during incubation, for a maximum time of 120 hours. The Embryo Real-time Culture Dish (MC 2004) is intended for preparing, storing and transferring human embryos. It is intended to be used only with the Embryo Real-time Incubator (TLS301). Embryo Realtime 2S Software and Embryo Realtime 3E Software accessories for the Embryo Real-time Incubator (TLS301). The Embryo Realtime 2S Software is intended to store, archive and transfer data. In addition, the Embryo Realtime 2S Software includes functions for managing models and performing calculations based on image data and embryo development parameters. Embryo Realtime 3E Software is intended for viewing and recording embryo development events from images captured using the Embryo Real-time Incubator (TLS301). Embryo Realtime 3E Software includes a user annotation for capturing information on embryo development parameters and a user-defined modeling function that allows the user to combine annotated information on embryo development parameters to aid in embryo selection. Embryo Realtime 2S Software and Embryo Realtime 3E Software do not control any hardware components in the Embryo Real-time Incubator (TLS301). Embryo Realtime 2S Software and Embryo Realtime 3E Software are provided in different software package and must be used together.

The Embryo Real-time Incubator (TLS301) consists of the following components: - Embryo Real-time Incubator, integrated with temperature control system, gas supply control system and time-lapse imaging system. - Image capture software - Workstation, composed of server and workstation software. - Embryo Real-time Culture Dish (MC 2004) The Embryo Real-time Incubator (TLS301) is a benchtop tri-gas (CO2, N2, and air) embryo incubator with a built-in microscope for time-lapse imaging intended to be used for the culture and monitoring of embryos used in Assisted Reproductive Technology (ART) procedures. It provides temperature control, gas control, and time-lapse imaging at multiple focal planes. The incubator chamber has the capacity to hold up to ten Embryo Real-time Culture Dishes (MC 2004). Each chamber contains a heating plate to maintain chamber temperatures. Gas (CO2, N2, and air) is mixed in a mixing chamber and passed through a HEPA/VOC filter prior to delivery to the incubation chamber. The built-in microscope consists of an illumination unit (red LED, 635 nm) and an inverted microscope/camera unit. The imaging system is mobile and is controlled through moving guide rail to automatically position the camera to the designated culture plate/well. The camera can acquire images in multiple focal planes. The time-lapse imaging system in the incubator along with the image capture software capture timelapse images of the embryos and transmit captured images to the computer for display and storage. The image capture software also reads the patient labels on the Embryo Real-time Culture Dish (MC 2004) and incorporates patient information into the imaging record. The workstation includes a server and workstation software (Embryo Realtime 3E Software). It includes graphical user interface and receives and stores images. It also supports query, retrieval and display of the embryo images. The workstation software allows for manual annotation of the series of images obtained through time-lapse imaging into a user-defined model for the assessment of embryo's development. In addition, the server software (Embryo Realtime 2S Software), that does not include a graphical user interface, is designed to archive, transfer and store images of embryos from the time lapse incubator and performs user model management and calculations based on image data and user inputted embryo development parameters. The two software are used together. The Embryo Real-time Culture Dish (MC 2004) is a single use, single-patient, polystyrene, radiation sterilized culture dish intended for preparing, storing, and transferring human embryos. It is intended to be used only with the Embryo Real-time Incubator (TLS301). It contains two types of wells for rinsing and handling the embryos before or after incubation and 16 wells for culturing the embryos during incubation. Each culture well is used to culture one embryo and a total of 16 embryos from a single patient can be cultured on one dish. The culture and rinsing wells have a volume of 30 µL and 50 µL, respectively. There is a central depression in the center of each culture well, where the embryo resides. The Embryo Real-time Culture Dishes (MC 2004) has a label area for unique identification of the culture dish.