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510(k) Data Aggregation
(30 days)
The Enbio PRO is an air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of dental and medical instruments that are validated to be sterilized by steam. The Enbio PRO has not been designed to sterilize liquid loads, biomedical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and/or damage to the autoclave.
Please refer to the table below for program name, load description, sterilization temperature, exposure time, drying time and maximum load.
| Program Name | Load Description | Sterilization Temperature | Sterilization Time | Drying Time | Maximum Load |
|---|---|---|---|---|---|
| 134°C | solid objects, small porous objects, simple objects recessed, narrow-clearance items, dental handpieces, and textiles; wrapped and unwrapped | 134°C (273°F) | 4 minutes | 4 minutes | 1.6 Kg/ 3.52 lbs |
| 121°C | solid objects, small porous objects, simple objects recessed, narrow-clearance items, dental handpieces, textiles, and plastics; wrapped and unwrapped | 121°C (250°F) | 30 minutes | 5:30 minutes | 1.6 Kg/ 3.52 lbs |
| 134°C FAST* | solid objects, non-porous objects, simple instruments (such as scissors, handles, pliers, chisels, probes, etc.), and dental handpieces; unwrapped | 134°C (273°F) | 4 minutes | N/A | 1.6 Kg/ 3.52 lbs |
*Immediate Use Steam Sterilization cycle
The Enbio PRO is an air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It has a hermetically sealed, heated chamber made from aluminum, with two heaters sink inside chamber walls. Inside this chamber, the sterilized load is placed on a special perforated tray. After closing the chamber, the user selects the appropriate sterilization program through the TFT touch screen.
The actual sterilization phase starts after the pre-vacuum phase. The aluminum steam generator produces superheated steam and applies it inside the chamber. That steam penetrates the sterilized instruments. The set temperature is maintained inside the chamber depending on the selected sterilization cycle (121C° or 134°C), during a specified time (30 minutes or 4 minutes). After that time all the steam accumulated inside the chamber is pumped out and the drying cycle begins. When sterilization is finished, device displays to the user that process is completed, and that the load is sterile. The user can then safely open the chamber and remove tools.
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