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The T-Top 10 & T-Top 11 tabletop autoclaves are designed for the sterilization of medical and surgical goods such as wrapped and unwrapped solid, hollow, and porous loads used in health care facilities (e.g., hospitals, nursing homes, extended-care facilities, freestanding surgical centers, clinics, and medical & dental offices). The T-Top 10 and T-Top 11 devices are validated for use in: - · Unwrapped instruments, wrapped instruments and dental handpieces (Class S cycles). - · Unwrapped instruments, wrapped instruments, sterilizing dental handpieces and textiles/porous loads (Class B cycles).

The autoclave is fully automatic (a computerized control unit ensures a fully automatic sterilization cycle, control and monitoring of physical parameters and a clear documentation of the sterilization cycle. Drying is performed with the door closed). This autoclave uses steam as a sterilizing agent. The steam is produced by warming up a controlled amount of water inserted to a pipe heating element, and then to the chamber. This technique saves energy and water consumption. The autoclave is equipped with a Pipe heating element and with chamber heaters to maintain the steam inside the chamber. The autoclave is equipped with a vacuum system, which supports and improves: - . Removal of residual air from packs and porous load and most kinds of tubes (rubber, plastic etc.) by vacuum at the first stage of the cycle. - . Steam penetration into the load; resulting in effective sterilization. - . Temperature uniformity. - . Post sterilization drying phase A touchscreen is used for monitoring and control purposes. The device has 2 built -in USB ports to enable the operation of an external optional barcode printer: - The barcode printer can print labels with a unique cycle ID barcode, operator name, . sterilization and expiry dates - . One barcode printer can be connected to the machine. - The printer connection to the machine, by using a USB socket, with a dedicated cable . - Barcode printer power supply voltage can range between 100-240V (external power . supply - not from the USB socket). - . A barcode printer is an optional addition to the autoclave The device features built-in memory to record up to 500 sterilization cycles. These can be exported to a USB device to be transferred to a PC. The T-Top 10 autoclave has one configuration only, whereas T-Top 11 has two configurations (available upon request) - a manually filled reservoir of demineralized water or an automatic / direct inlet of demineralized water from the water supply system. The T-Top 10 has a manually filled reservoir of demineralized water only. There is a demineralized water overflow outlet at the rear, and a demineralized water overflow, and wastewater outlet is located on front. Automatic water quality checking will alert the user of poor water quality, protecting the autoclave chamber from corrosive minerals found in poor quality water. The T-Top 10 & T-Top 11 feature a built-in memory to record up to 500 sterilization cycles. The T-Top 10 & T-Top 11 have a built-in USB port to enable exporting this data to a USB device, to be transferred to a PC. The built-in USB port also enables the operation of an external, optional barcode printer, by using a dedicated cable - the barcode printer can print labels with a unique cycle ID barcode, operator's name, sterilization and expiry dates. One barcode printer can be connected to the machine. There is Wi-Fi connection available to customers (optional). If the unit is connected to Wi-Fi, this enables remote diagnostics and issue resolution from Tuttnauer. The software has been validated and cybersecurity has been considered for this option - see software reports in the 510(k) file. The chamber is made of a corrosion-resistant 304L stainless steel, and the door is made of corrosion-resistant 304L stainless steel. The outer covers are made of polycarbonate.