Search Results

Harioculture TL-16 Time-lapse Incubator consists of the following devices with the following indications for use: Time-lapse Incubator provides an environment with controlled temperature and gas concentrations (CO2 and O2) or mixed gas (CO2 and other gases) for the development of embryos at or near body temperature. Use of the Time-lapse Incubator is limited to five days (120 hr) covering the time from post insemination to day five of development. The Hariomed culture dish is intended for preparing, storing, and transferring human embryos. The Hariomed culture dish must be used together with the Time-lapse Incubator. The Harioculture-client software is intended for displaying, comparing, storing, and transferring images generated by the Time-lapse Incubator. This software includes a user annotation function for capturing information on embryo development parameters as well as a user-defined modeling function, which allows the user to combine annotated information on embryo development parameters to aid in embryo selection. The Harioculture-client software does not control any hardware components in the Time-lapse Incubator. The Harioculture-server software is intended to store, archive and transfer data. In addition, this software includes functions for managing models and performing calculations based on image data and embryo development parameters. The Time-lapse Incubator, Harioculture-client software, and Harioculture-server software must be used together to export embryo images from the Time-lapse Incubator. The Harioculture-client software and Harioculture-server software must be used together to assist users to analyze the embryo images.

Harioculture TL-16 Time-lapse Incubator consists of the following components: - Time-lapse Incubator, - Harioculture-server software, - Harioculture-client software, - Hariomed culture dish. The Time-lapse Incubator is a benchtop 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 microscopy at multiple focal planes. This device can hold up to 16 culture dishes (Hariomed culture dish) in the culture cabin. The device can be connected to the capacity expansion module which in turn can also accommodate 16 culture dishes. The capacity expansion module is similar to the main incubator and provides the same culture capacity as the incubator host. However, it cannot be run independently and needs to be used together with the Incubator host. The incubator host includes the software to control the temperature, gas concentration, imaging as well as image display on the incubator screen. The culture dishes are placed in the culture slots on the turntable in the Time-lapse Incubator. The culture slots provide direct heat transfer to the Hariomed culture dishes. The built-in microscope consists of an illumination unit (red LED, 630±5 nm) and an inverted microscope/camera unit. During image acquisition, turntable is rotated to position individual culture dishes on the microscopy system and image stacks are acquired for individual embryos in each culture dish. The Time-lapse Incubator supports two gas control and culture modes: - **Self-mixed mode** – Under the self-mixed gas culture mode, CO2, and N2 gases are supplied from medical grade gas cylinders. These gasses (CO2, N2 and re-flux gas) are mixed in a mixing chamber and passed through a HEPA/VOC filter prior to delivery to the culture cabin. This culture mode does not allow for humidification of the chamber (dry-culture mode). - **Pre-mixed mode** – Under the pre-mixed gas culture mode, the gas is supplied from standard premixed medical gas cylinders. Pre-mixed gas passes through the HEPA/VOC filter and a humidification box to form a humidified gas which then enters the culture cabin. The humidification box is sterile, single-use component with a sterility assurance level (SAL) of 10-6 and a shelf-life of two years. The pre-mixed culture mode allows humidification of chamber (wet-culture mode). The Hariomed culture dish is a single use, single-patient, polystyrene, radiation sterilized culture dish intended for preparing, storing, and transferring human embryos. The Hariomed culture dish is intended for use only with Harioculture TL-16 Time-lapse Incubator and includes two culture ponds. Each culture pond has eight microwells and a total of 16 embryos from a single patient can be cultured on one dish. Each dish includes four rinsing wells for rinsing and handling the embryos before or after incubation. The dishes have area for unique barcode labels that can be printed through the Harioculture-client software. The barcode labels provide patient identification information. The Hariomed culture dish has a sterility assurance level (SAL) of 10-6 and a shelf-life of two years. The Harioculture-client software is intended for displaying, comparing, storing, and transferring images generated by the Time-lapse Incubator. The data that can be viewed using this software includes embryo images, incubation details, alarms, log files and other instrument parameters. This software also includes a user annotation function for capturing information on embryo development parameters as well as a user-defined modeling function, which allows the user to combine annotated information on embryo development parameters to aid in embryo selection. The Harioculture-client software does not control any hardware components in the Time-lapse Incubator. The Harioculture-server software allows users to update and view common data. The server acts as the central unit, which stores data and controls the data flow to and from the connected devices. The server can be connected to multiple Time-lapse incubators and computers with the Harioculture-client software.