UV Smart D60

CE Certificate

The UV Smart D60 device received CE certification in April 2022 (MDR Class IIa).

Health Canada

The UV Smart D60 is registered with Health Canada as a Class II medical device.

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 D60 complies with the general safety requirements for medical electrical equipment.

The EN 14885 standard is used as a reference for the D60 (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 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 technology for guaranteed disinfection without damaging equipment and with validated and continuous effectiveness.

For disinfection of:

Channel-less ENT scopes and TEE-probes

Dimensions:

• Width: 33.8 inches
• Depth: 18.6 inches
• Height: 80.0 inches

Power cable:

• Length: 6.6 feet

Disinfection cycle:

• 60 seconds

Effective against:

• Viruses
• Bacteria
• Spores
• Yeast
• Fungi
• Mycobacteria
• Tuberculin

Compatibility:

Compatibility tests were performed on several products from Pentax, Olympus, Xion and Karl Storz with the D60 to verify the impact of UV based technology on endoscope materials. The conclusion is very positive and the D60 has therefore received multiple compatibility approvals.

The disinfection efficiency of the UV Smart D60 has been validated and proven by extensive research conducted in medical centres such as: Spaarne Gasthuis (Netherlands), Marburg University (Germany) and UZ Gent (Belgium). Studies have also been conducted in clinical laboratories (and institutions), including Streeklab Haarlem (Netherlands), and Eurofins (Italy).

Eurofins and Streekklab Haarlem*

Eurofins and the Streekklab concluded that D60 meets the European standard for cleaning and disinfection of medical devices.

Conclusion: D60 meets the NEN-EN-14885:2018 standards for the full spectrum of micro-organisms.

Spaarne Gasthuis*

Spaarne Gasthuis compared the D60 with standard washer disinfectors.

The conclusion: the first part of the laboratory research showed that the D60 complies with the reduction requirements for S. aureus, C. albicans, S. pneumoniae, B. subtilis and E. coli. The second part of this study found that, on average, the D60 showed a visible improvement in terms of disinfection compared to the current method: the washer disinfector.

Marburg University*

After favorable results of disinfection of rigid endoscopes using Impelux™ technology, Marburg University investigated the effectiveness of the disinfection of channel-less flexible endoscopes using the D60.

The conclusion of the study is that the D60 efficiently reduces bacterial contamination of flexible endoscopes.

UZ Gent*

UZ Gent investigated the effectiveness of the disinfection of TEE probes in the D60.

The conclusion: A clear reduction of the number of CFU is noticeable after disinfection with the D60. The handle contains noticeably fewer germs after disinfection with the D60 compared to the Soluscope.

*Research is available on request from info@uvsmart.nl

Does the light reach everything in the D60?

The combination of Impelux™ technology, a glass holder, and high reflection ensures that the UV based light in the D60 gets everywhere. This allows the scope to be disinfected properly. The D60 cannot disinfect ENT scopes with working channels, because the light cannot reach inside the ENT scope.

Does the device have a 'track and trace' system?

Yes, there is a track and trace system in the D60. The person using the D60 must scan their badge as well as the instrument they will be disinfecting before the D60 opens. After the cycle, the person is asked to scan their badge again, after which the door can once again be opened.

What is the best place for the D60?

The D60 is preferably placed within the ward, as this saves the most time. However, because the D60 only needs a 110v or 220v outlet, it can be placed anywhere in the hospital as required.

What about compatibility?

Check the compatibility of the UV Smart D60 device with available channel-less END endoscopes and TEE probes on this page, where you can also request a statement of compatibility directly from UV Smart.

The D60 has received a compatibility declaration from organizations such as Xion and Pentax. Research has shown that the D60 does not damage their scopes. Compared to chemicals, the scopes in the D60 remain as new.

How many scopes can be disinfected at the same time?

The D60 is designed to disinfect one single scope at a time. This process takes just 60 seconds, therefore hanging multiple devices inside the unit for disinfection does not save the user any time as this process would take even longer. In fact, doing this would diminish the effectiveness of the disinfection cycle and is not recommended.

Does manual pre-cleaning still need to be carried out?

Yes, pre-cleaning with a cloth (microfibre) and water works perfectly. Hospitals are free to organize the pre-cleaning process themselves, as long as the scope is visually clean. Watch this instructional video for more information.