State of the art technology!
The 4DIR sensor is currently the only commercially available instrument that ensures the control of sterilization conditions as required by regulations such as EN 285: 2015 and ISO 17665-1:2006 clause 10.1 by state-of-the-art direct measuring the sterilant conditions.
Which are the benefits?
Since every sterilization cycle is a unique event, most of the benefits in terms of safety come from continuously monitoring steam penetration throughout each cycle, in addition 4DIR sensor:
• Provides a numeric indication of the steam saturation to define a 'pass', a ‘pass with warning’ or a 'fail'. A pass with a warning alerts users that the sterilizer may need maintenance but currently the sterilization conditions comply with the specifications in the standards.
• Provides traceability of the steam penetration by recording the 4DIR sensor cycle data, reducing handling time and potential human errors thus improving patient safety. Digital tests and traceability guarantee savings in a very short time.
• Performs a “self-test” before each steam penetration test cycle: a unique automatic feature not available in any other chemical or biological indicator or digital device.
• Steelco 4DIR sensor exceeds the challenge of the Bowie & Dick test and is third party certified (it is also certified as class 6 PCD Helix test).
How does the 4DIR sensor work?
It measures steam saturation, the only parameter which can guarantee that sufficient steam is present in the sterilizer chamber and load and that there are no excessive residues of non-condensable gasses. The measurement takes place at the close end of a long narrow channel (70 cm) in the chamber to simulate a worst-case scenario of the most challenging hollow surgical instruments. An emitted infrared radiation is filtered by the steam according to its concentration level:
The greater the absorption of IR light by steam,
the higher the saturation of steam
Steam presence and steam penetration are proven, monitored and registered in real time during the sterilization plateau every single second together with the other relevant cycle parameters.
A practical guide is available, it includes:
• Questions and Answers to quickly get into the topic on how the 4DIR sensor technology can improve your sterilization process safety.
• Scientific literature and additional comments.
• Deep dives on related topics.