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The System 2S Steam Sterilizer is designed for efficient, point-of-use sterilization of nonporous and porous, heat and moisture-stabile materials used in outpatient surgery, ambulatory care and urgent care centers. The System 2S Steam Sterilizer is available in one configuration: Prevacuum 16"diameter x 26"length chamber size.

The System 2S Steam Sterilizer is equipped with the following factory-programmed set sterilization cycles and cycle values:

| CYCLES | RECOMMENDED
LOAD | STERILIZE
TEMP. | STERILIZE
TIME | DRY TIME |
|----------|-------------------------------------------------------------|--------------------|-------------------|------------|
| FLASH | Unwrapped
Instrument Tray with
single instrument | 270°F (132°C) | 3 minutes | 1 minute |
| GRAVITY* | Fabric Pack · | 250°F (121°C) | 30 minutes | 15 minutes |
| PREVAC** | Double Wrapped
Instrument Tray | 270°F (132°C) | 4 minutes | 30 minutes |
| EXPRESS | Single Wrapped
Instrument Tray with
single instrument | 270°F (132°C) | 4 minutes | 3 minutes |

*250°F Cycle can be adjusted from factory-set value of 15 minutes dry time to 30 minutes dry time for instrument trays.

** 270°F Cycle can be adjusted from factory-set value of 30 minutes dry time to 5 minutes dry time for single fabric pack.

The System 2S Steam Sterilizer is a Class II medical device as defined by 21 CFR Part 880.6880. The System 2S Steam Sterilizer is a sliding door sterilizer intended for the terminal sterilization of surgical instruments, various hospital utensils and other surgical materials and supplies to be used for human diagnostic or therapeutic procedures.

The System 2S Steam Sterilizer cycle descriptions are as follows:

• FLASH Cycle is provided for quick turnaround processing of nonporous goods (e.g. dropped instruments) at 270°F (132°C) for 3 minutes sterilize and 1 minute dry;
• GRAVITY Cycle is provided for the sterilization of heat and moisture stabile goods at 250°F (121°C) for 30 minutes sterilize and 15 minutes dry;
• PREVAC Cycle is provided for the sterilization of heat and moisture stabile goods at 270°F (132°C) for 4 minutes sterilize and 30 minutes dry;
• EXPRESS Cycle is offered for rapid processing of single-wrapped instrument trays at 270°F (132°C) for 4 minutes sterilize and 3 minutes dry;
• DART (Bowie-Dick Test) Cycle is provided for verification of effective removal of residual air in the chamber and load during testing. This cycle is pre-programmed and fixed; and
• LEAK Test Cycle is provided for verification of door seal and piping system integrity and is pre-programmed and fixed.

Here's an analysis of the provided text regarding the STERIS System 2S Steam Sterilizer, focusing on acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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