Frequently Asked Questions

It is a low-temperature, general-purpose sterilizer for processing heat-sensitive (thermolabile) instruments.

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Steam:

• The 125L is an adjunct to steam
• Runs at a much lower temperature - approximately 95°F (32 °C)
• Runs for a longer cycle time
• The cost to operate is similar

EtO:

• The 125L runs fort a much shorter cycle time
• Costs much less to operate
• Is much safer - no toxic byproducts
• Has a similar capacity

Hydrogen Peroxyde Plasma:

• The 125L costs less to operate - no sterilant to buy
• Is safer - no risk of spills/skin burns
• Runs for a longer cycle time but has a similar throughput

TSO₃ has FDA clearance for stainless steel instruments, hinged instruments and instruments with rigid stainless steel lumens falling into the following dimensions (No lumen quantity limitation in chamber):

- With inside diameters >0.9 mm and with a length of 485 mm or less

- With inside diameters >1 mm and with a length of 500 mm or less

- With inside diameters >2 mm and with a length of 575 mm or less

- With inside diameter >3 mm and with a length of 650 mm or less

- With inside diameter >4 mm and with a length of 700 mm or less

TSO₃ also has Health Canada clearance for stainless steel instruments, hinged instruments and instruments with rigid stainless steel lumens falling into the following dimensions (No lumen quantity limitation in chamber):

- With inside diameters >0.5 mm and with a length of 450 mm or less

- With inside diameters >1 mm and with a length of 500 mm or less

- With inside diameters >2 mm and with a length of 570 mm or less

- With inside diameter >3 mm and with a length of 650 mm or less

- With inside diameter >4 mm and with a length of 700 mm or less

TSO₃ will continue to confirm material compatibility test results for most instruments used in minimall- invasive surgery (MIS), such as rigid endoscopes, cameras, couplers and related accessories.

Obtain the list of compatible materials and processes.

In addition to those items excluded above, the system is not intended for use in processing any flexible endoscopes, glass or plastic ampoules, liquids or implants.

Materials such as latex and textile fabrics should not be processed.

Ozone is an oxidative gas, which quickly and effectively deactivates microorganisms by denaturing cell membranes. Ozone is a naturally occurring gas comprised of three oxygen atoms, characterized by an odour often described as the way the air smells following a thunderstorm.

The sterilizer received 510(k) clearance from the FDA based on test results that confirm the product's ability to sterilize devices to a 10-6 sterility assurance level. Copies of the 510(k) clearance letter and summary, as well as a technical white paper, are available upon request. Additionally, you can monitor the system using an FDA-cleared Biological Indicator and Chemical Indicator specific to ozone sterilization.

The sterilizer has been tested with a variety of organisms, including G. Stearothermophilus, which is considered the most resistant organism to an oxidative sterilization process. The FDA required test results utilizing a large variety of organisms known to be resistant to many sterilization processes as the basis of the 510(k) review process.