UV Smart D25
The UV Smart D25 is designed for fast and highly effective disinfection of non-invasive medical devices, electronics and other small equipment in hospitals, health centres, nursing homes and laboratories.
Description
In 2020, UV Smart commercialized the D25: a CE Class IIa medical device for automated UV-C surface disinfection of medical (non-invasive) equipment in just 25 seconds.
The importance of good hygiene and disinfection of medical equipment is well known. The ever-increasing Healthcare Acquired Infections (HAI’s), including Corona cases, reaffirm that more measures are needed to prevent further spread. Disinfection with wipes has limitations, the D25 is the perfect solution to protect employees and patients against bacteria and viruses.
The D25 offers an automated and consistent disinfection by means of the patented Impelux technology, which works on the basis of UV-C light. This light ensures that DNA and RNA of microorganisms are inactivated, leaving them harmless.
Key values of the D25
- CE Certified Class IIa for surface-disinfection of medical (non-invasive) devices and personal items;
- Clinically validated by Dutch and German healthcare institutes;
- A minimum of LOG 4 reduction in 25 seconds;
- Acts on full spectrum of resistant infection-causing microbes (incl. Noro, MRSA and Covid-19);
- Simple & safe to use;
- No waste, no use chemicals, less time and no room for manual error;
- Low energy consumption;
Video
Technical specifications
| Device | |
|---|---|
| Width: | 557 mm |
| Depth: | 489 mm |
| Height: | 297 mm |
| Disinfection chamber | |
| Width: | 380 mm |
| Depth: | 225 mm |
| Height: | 150 mm |
| Power cable length: | 2m |
| Effective against | Bacteria, spores, yeast, fungi, mycobacteria, tuberculin and viruses |
| Currently used by | Radboudumc, Amsterdam UMC, RKZ Beverwijk and more |
CE Certificate
The D25 was CE-certified on 19 May 2020 (MDD Class IIa).
Standards
Our product complies with NEN-EN 60601-1 (Medical electrical equipment - General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests).
This certificate indicates that the D25 complies with the general safety requirements for medical electrical equipment.
The EN 14885 standard is used as a reference for the D25 (Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics). This certification means that the equipment achieves the same level of disinfection as wipes and liquids (as there is currently no guideline for UV-C).
UV Smart Technologies B.V. has held the NEN-EN-ISO 13485 certificate since May 2020. This certification is the international standard for manufacturers, suppliers and distributors of medical devices to show that they comply with the legal requirements for medical devices.
Patent protection
Impelux™ is a patented technology that uses UV-C for guaranteed disinfection without damaging equipment and with validated and continuous effectiveness.
Clinical evidence
The disinfection efficiency of the UV Smart D25 has been proven and supported by numerous extensive studies conducted in clinical settings at academic medical centres (University Medical Centre Groningen, University Medical Centre Amsterdam and Radboud University Medical Centre in the Netherlands) and laboratories (Eurofins and Streeklab Haarlem, the Netherlands). These studies have proven that the UV Smart D25 is very effective on the full spectrum of micro-organisms.
The D25 achieves at least a log-4 reduction in microbial counts in 25 seconds on the hard, non-porous surfaces of non-invasive medical devices. The UV Smart D25 was also able to achieve significant log reduction of methicillin-resistant Staphylococcus aureus, van-comycin-resistant enterococci (VRE), the family of Corona viruses, Norovirus and Escherichia coli.
*These studies are available on request at info@fmhmedical.nl.
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